Clinical trial · Interventional
TaxXel: Taxotere and Xeloda in Esophageal Cancer
A Phase I/II Study on the Treatment With Taxotere in Combination With Xeloda in Patients With Metastatic Oesophageal Cancer or Cancer in the Cardia Region
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of Taxotere in combination with Xeloda which is dose escalated during the first phase of the study (modified Fibonacci design) and fixed during the second phase. The primary objective of the phase 1 part is to define the dose recommended for the Phase II part of the study. The primary objective is to determine the response rate.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Esophagus | Malignant Esophageal Neoplasm | ALIAS | 0.90 |
| Gastric Cardia Carcinoma | Gastric Cardia Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Taxotere Xeloda
- description
- Taxotere i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule. Xeloda orally day 1-14 every 3 weeks.
- interventionNames
- Drug: Docetaxel
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Response rate
- description
- Response rate will be defined as the percentage of patients who achieve a complete response (CR) or partial response (PR). Duration of a CR or PR will be calculated from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.
Secondary outcomes (3)
- measure
- CT scan
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia. * Inoperable metastatic disease * Performance status (WHO) of 0-2 * Measurable disease. * Adequate hematological, liver and renal function. * Signed informed consent. Exclusion Criteria: * CNS metastases * Symptomatic peripheral neuropathy equal to or greater than NCI grade 2. * Other concomitant serious illness or medical condition. * Past or current history of malignant neoplasm other than oesophageal carcinoma. * \<18 years of age. Pregnant or lactating patients.
References
Publications (0)
Data not yet available